FDA.reportPublic FDA data

NDC 80777-345-01 - mRESVIA

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
80777-345
Requested NDC
80777-345-01
Package NDCs from labels
80777-345-01, 80777-345-90, 80777-345-96, 80777-345-89, 80777-345-62, 80777-345-63, 80777-345-61
Manufacturer
Moderna US, INC. | ModernaTX, Inc.
Effective date
2026-08-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
mRESVIA - Moderna US, INC. | ModernaTX, Inc.Moderna US, INC. | ModernaTX, Inc.2026-08-07VACCINE LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80777-345-01mRESVIA0.5 mL in 1 SYRINGESUSPENSION0.55
80777-345-61mRESVIA10 in 1 CARTONSUSPENSION105
80777-345-62mRESVIA1 in 1 CARTONSUSPENSION15
80777-345-63mRESVIA2 in 1 CARTONSUSPENSION25
80777-345-89mRESVIA2 in 1 CARTONSUSPENSION25
80777-345-90mRESVIA1 in 1 CARTONSUSPENSION15
80777-345-96mRESVIA10 in 1 CARTONSUSPENSION105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80777-345MRESVIA (RESPIRATORY SYNCYTIAL VIRUS VACCINE) SUSPENSION [MODERNA US, INC.]4Current NDC, 7 package rows20241226_e5c837e7-41e8-496a-9c85-6b0453b35948.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80777-345-01ML - Milliliter80777-345639c9de3-5187-4b1d-be42-2a6600e8468a12024-07-12
80777-345-61ML - Milliliter80777-345c4159982-34cb-4954-9d0c-44d72e764a2912025-09-12
80777-345-63ML - Milliliter80777-3451c997840-0d97-407f-bc70-517756e43a5c12025-09-12
80777-345-90ML - Milliliter80777-3457b14b36b-f28d-4ca3-bc22-d87db62aa2fd12024-07-12
80777-345-96ML - Milliliter80777-34594df3056-82b3-4035-9eee-12e64c1fb91712024-07-12

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 5 of 18 · 347 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GallcillCHELIDONIUM MAJUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, DIOSCOREA VILLOSA, CALCAREA SULPHURICA, CUPRESSUS LAWSONIANA, HEPAR SULPHURICA CALCAREUM, CHOLESTERINUM, FEL TAURI, LYCOPODIUM CLAVATUM, MAGNESIA SULPHURICANucleic Products, LLCfaf3ac96-b744-448d-b41a-8370b3ef3c0c2025-12-03WarningsExact identifier
unii: 97C5T2UQ7J
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsExact identifier
unii: 059QF0KO0R
ULINE EyewashEYEWASHNiagara Pharmaceuticals Inc.2d7f22d2-320b-6af1-e063-6294a90addc62025-11-24WarningsExact identifier
unii: 059QF0KO0R
Pur-WashEYEWASHNiagara Pharmaceuticals, Inc.0d43b1c1-2699-37f1-e054-00144ff88e882025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
SKIN TAG REMOVERSALICYLIC ACIDShenzhen Yaozhihong Technology Co., Ltd.4246d4d5-9955-ba5a-e063-6394a90a84482025-10-29WarningsExact identifier
unii: Q40Q9N063P
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.